Acucy Calibration Device - 1031
Device Description
A solid phase or liquid reference standard of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical laboratory instrument (e.g., spectrophotometer, nephelometer, microplate reader). It is typically presented as a solid/sealed cuvette or a multiple-well test plate and may include filters or a light source emitted at specified wavelengths. Verification/optimization functions may include optical density (absorbance/scattering), fluorescent or luminescent accuracy, linearity, repeatability and/or limit of detection readings, and optical alignment and precision of the instrument/analyser. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PSZ
Device Name: Devices Detecting Influenza A, B, And C Virus Antigens
Device Class: 2
Physical State: Devices detecting influenza A, B, and C virus antigens are in vitro diagnostic devices that consist of reagents and associated instrumentation for the detection and identification of influenza virus antigens
Definition: An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.
Submission Type ID: 1
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: A qualitative in vitro diagnostic assay that detects and identifies influenza virus antigens
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: In vitro diagnostic device
Regulation Number: 866.3328
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 00742860100345
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A